Bortezomib in Treating Patients With Mantle Cell Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00030875
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed mantle cell lymphoma.
* Determine the toxicity of this drug in these patients.
* Correlate suppression of 20S proteasome levels with toxicity of and response to this drug in these patients.
* Determine the time to progression and response duration in patients treated with this drug.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 courses beyond documentation of CR. Patients with stable disease receive a maximum of 4 courses. Patients with partial response (PR) continue therapy until disease progression or for 2 courses beyond documentation of stable PR.
Patients are followed at 4 weeks and then every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Maisonneuve-Rosemont Hospital
🇨🇦Montreal, Quebec, Canada
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Kingston Regional Cancer Centre
🇨🇦Kingston, Ontario, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
🇨🇦London, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Ontario, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada